12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BAXTER ACCURA SYSTEM, MODEL 5M5660
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HUNTER SCIENTIFIC INJECTION PIPETTES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
TAXUS¿ ELEMENT¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 26, 2013
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·March 10, 2011
*
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP.·Product code ESW·February 25, 2008
GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 2)
FDA Adverse Event
ABBOTT DIABETES CARE INC.·Product code MDS·May 19, 2021
BD POSIFLUSH¿ NORMAL SALINE SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FOZ·March 15, 2023
BD POSIFLUSH¿ NORMAL SALINE SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FOZ·March 15, 2023
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020